Diabetic Foot UlcerNCT03905863
The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
A study testing Natrox® Oxygen Wound Therapy in people with Diabetic Foot Ulcer and Surgical Wound, run by Inotec AMD Limited at 20 sites in 2 countries.
Trial summary
A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Surgical Wound
- What is being tested?
- Natrox® Oxygen Wound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 4 Jun 2019to 18 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are male or female, 18 years of age or older. At least 50% of the enrolled population must be ≥ 65 years of age.
- Subjects with one of the following wounds:
- Diabetic foot ulcer present for greater than 4 weeks (documented in the medical record) but less than 12 months duration if being treated with active SOC.
- Minor amputation wound sites
- Subject has clinical documentation of no visible wound improvement in the after 4 weeks of standard of care. Objectively, less than 40% healing in the past four weeks from the first treatment visit.
- Study ulcer is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit
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- Subjects' wound score on ISDA tool is Grade 1 or 2.
- The subject is able and willing to follow the protocol requirements
- Subject has signed informed consent
- Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg; an ABI between 0.7 and ≤ 1.3, or TBI of >6 within 3 months of the first Screening Visit.
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
- The target ulcer has been offloaded for at least 14 days prior to randomization.
Who cannot join
- Subject has a known life expectancy of < 1 year
- Subject or caregiver is unable to manage the Natrox® device (charge and change batteries daily)
- Subject has ulcers that are completely necrotic or if the clinician feels it is clinically necessary to cover the wound surface in gel or creams that would prevent the transmission of oxygen to the wound surface.
- Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
- Subject currently being treated for an active malignant disease or subjects with history of malignancy within the wound.
- The Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety
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- Known contraindications for the Natrox system
- Known allergies to any of the Natrox system components
- Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
- Index ulcer has reduced in area by 20% or more after 2 weeks of standard of care from the first screening visit (S1) to the TV1/randomization visit.
- Subject is pregnant or breast feeding.
- Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days preceding the first treatment visit.
- Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of treatment visit 1.
- Known HbA1C >12%
- An ulcer that has visible signs of improvement in the four weeks prior to randomization defined objectively as a 40% reduction in surface area in the four weeks prior to enrollment.
- An ulcer that has healed by more than 20% in the 2 weeks prior to screening: "historical" run-in period.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States19 sites
Cleveland Foot and Ankle Clinic
Cleveland, Ohio, 44103
El Campo Memorial Hospital
El Campo, Texas, 77437
The Foot and Ankle Wellness Center of Western Pennsylvania
Ford City, Pennsylvania, 16226
Allure Health LLC
Friendswood, Texas, 77546
Pinnacle Foot and Ankle Center
Houston, Texas, 77054
Antria
Indiana, Pennsylvania, 15701
ACMH Snyder Institute
Kittanning, Pennsylvania, 16201
Wahab Consulting and Research
Las Vegas, Nevada, 89148
New Hope Podiatry Clinic
Los Angeles, California, 90063
MedCare Research
Miami, Florida, 33165
San Marcus Research Clinic
Miami Lakes, Florida, 33014
Global Health Research Center Inc
Miami Lakes, Florida, 33016
Barry University Clinical Research
North Miami Beach, Florida, 44169
Royal Research Corp
Pembroke Pines, Florida, 33027
SerenaGroup Research Institute
Pittsburgh, Pennsylvania, 15222
Doctors Research Network
South Miami, Florida, 33143
Tulsa Bone and Joint
Tulsa, Oklahoma, 74146
Mercury Clinical Research
Webster, Texas, 77598
Pharma Research Associates
Westchester, Florida, 33155
Puerto Rico1 site
Clinical Research Management Group
Coto Laurel, Ponce, 00780
About this study
Official title: A Randomized Controlled Multicentre Trial, Examining the Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.
Read the detailed description
Patients with diabetic foot ulcers will be enrolled into the trial at multiple wound care centers and hospital research centers across the United States of America. After qualifying per protocol, patients will be randomized to receive standard wound care or standard wound care plus Topical Oxygen Wound Therapy for their wounds. Patients will be monitored for 12 weeks. The primary comparator between the groups will be complete wound healing at 12 weeks, but other parameters will be assessed, such as pain, wound size reduction and infection status.
- Conditions
- Diabetic Foot Ulcer, Surgical Wound
- Being tested
- Natrox® Oxygen Wound Therapy
- Keywords
- topical oxygen, topical oxygen treatment, diabetic foot ulcer, non-healing wound, surgical site, pain, wound size, healing, infection
- Medical subject headings
- Diabetic Foot, Surgical Wound, Pain, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natrox® Oxygen Wound TherapyDevice
A battery-operated device which delivers pure humidified oxygen to the wound bed through water electrolysis via a sterile oxygen delivery system.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care arm | No intervention | SOC was defined to include wound cleansing with sterile water or saline solution, and gentle irrigation of the study ulcer with warm tap water; sharp debridement using a standardised protocol based on TIME principles for wound bed preparation; offloading with a TCC twice in the first week and weekly thereafter (all exceptions had to be agreed by the lead investigator; a fixed ankle walker boot or similar device was acceptable as an alternative, but shoe inserts were not deemed to provide sufficient offloading); moisture balance was provided using a hydrofibre or alginate dressing. In addition, patients were instructed on adherence to the protocol and given instructions to call their clinic if they suspected any signs of an infection. |
| Intervention arm | Active comparator | Same protocol as SOC only but were also provided with a Natrox® Oxygen Wound Therapy System, consisting of two elements: the Natrox® OG and the Natrox® ODS. The OG is a multi-use battery powered device which generates oxygen though water electrolysis at a rate of 15mL/hr. The ODS is a sterile, single use device that allows wound exudate to pass through to the secondary dressing while allowing the diffusion of oxygen across the wound bed. It connects directly to the OG via a thin flexible fine-bore tube. While the ODS can remain in situ for 7 days, it should be changed at each dressing change, based on exudate level or clinical judgement. This is a battery-operated system with a 30-hour battery life; the kit includes two interchangeable, rechargeable batteries. Each participant was advised to charge one battery while the other was in use, as the battery required changing daily. The oxygen generator is worn in a holster so that patients can remain ambulatory. Receives: Device: Natrox® Oxygen Wound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Achieve Complete Wound Closure During the Twelve Week Study and the Percentage Change in Participant Ulcer Size at 12 Weeks From Baseline.
Photographic wound evaluation and measurements were conducted utilizing an AI-driven computerized planimetry imaging system (Tissue Analytics, Inc., Baltimore, MD USA).15 This system obtained both 2D and 3D assessments of the wound at each visit through a standardized mobile device; in addition, the lead investigator reviewed all digital images.
Measured: Twelve (12) weeks from Time 0
Percentage Reduction in Ulcer Area (cm^2).
Wound size change over time using a wound imaging measurement system. Percentage change in ulcer area was calculated on the basis of area change from the start of the study to the final recorded value. Any healed ulcer was recorded as having achieved 100% reduction in area; positive values indicate a reduction in size over the 12-week period while negative values indicate that the ulcer increased in size.
Measured: Twelve (12) weeks from Time 0
Secondary outcomes (2)
Level of Pain of the Wound
Does pain associated with the wound change over time using a Visual Analogue Scale Pain intensity of the reference DFU is to be assessed before any dressing changes or other ulcer manipulations at all screening and treatment visits.
Subject will be asked to indicate a numerical value that best represents the pain intensity at ulcer site on a scale of 0 to 10 anchored by word descriptors at each end, as "no pain" on the left side and "worst possible pain" on the right side of the number line. The number 0 represent "no pain", the number 5 represents "moderate pain" and the number 10 represents the "worst possible pain". The subject indicates the level of pain intensity by selecting a number on the line that represents their perception of their current state.
Measured: Up to twelve (12) weeks from Time 0
Number of Adverse Events
Number of adverse events, such as infections, that are found associated with the study wound
Measured: Up to twelve (12) weeks from time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start4 Jun 2019
- Primary completion18 Oct 2020
- Study completion18 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inotec AMD Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Responsible party
- Sponsor
- Investigators
- Thomas Serena, Study director, SerenaGroup, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905863
- Sponsor's protocol ID
- 1
- Status last verified
- Nov 2021
- First submitted
- 3 Apr 2019
- Last updated
- 22 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multicentre Trial, Examining the Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03905863
- Acronym / sponsor ID
- 1
- Conditions
- Diabetic Foot Ulcer, Surgical Wound
- Keywords
- topical oxygen, topical oxygen treatment, diabetic foot ulcer, non-healing wound, surgical site, pain, wound size, healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Inotec AMD LimitedIndustry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 18 Oct 2020 (actual)
- Study completion
- 18 Oct 2020 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Posted 22 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.
Detailed description
Patients with diabetic foot ulcers will be enrolled into the trial at multiple wound care centers and hospital research centers across the United States of America. After qualifying per protocol, patients will be randomized to receive standard wound care or standard wound care plus Topical Oxygen Wound Therapy for their wounds. Patients will be monitored for 12 weeks. The primary comparator between the groups will be complete wound healing at 12 weeks, but other parameters will be assessed, such as pain, wound size reduction and infection status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care arm | No intervention | –SOC was defined to include wound cleansing with sterile water or saline solution, and gentle irrigation of the study ulcer with warm tap water; sharp debridement using a standardised protocol based on TIME principles for wound bed preparation; offloading with a TCC twice in the first week and weekly thereafter (all exceptions had to be agreed by the lead investigator; a fixed ankle walker boot or similar device was acceptable as an alternative, but shoe inserts were not deemed to provide sufficient offloading); moisture balance was provided using a hydrofibre or alginate dressing. In addition, patients were instructed on adherence to the protocol and given instructions to call their clinic if they suspected any signs of an infection. |
| Intervention arm | Active comparator | Device: Natrox® Oxygen Wound TherapySame protocol as SOC only but were also provided with a Natrox® Oxygen Wound Therapy System, consisting of two elements: the Natrox® OG and the Natrox® ODS. The OG is a multi-use battery powered device which generates oxygen though water electrolysis at a rate of 15mL/hr. The ODS is a sterile, single use device that allows wound exudate to pass through to the secondary dressing while allowing the diffusion of oxygen across the wound bed. It connects directly to the OG via a thin flexible fine-bore tube. While the ODS can remain in situ for 7 days, it should be changed at each dressing change, based on exudate level or clinical judgement. This is a battery-operated system with a 30-hour battery life; the kit includes two interchangeable, rechargeable batteries. Each participant was advised to charge one battery while the other was in use, as the battery required changing daily. The oxygen generator is worn in a holster so that patients can remain ambulatory. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects are male or female, 18 years of age or older. At least 50% of the enrolled population must be ≥ 65 years of age.
- Subjects with one of the following wounds:
- Subject has clinical documentation of no visible wound improvement in the after 4 weeks of standard of care. Objectively, less than 40% healing in the past four weeks from the first treatment visit.
- Study ulcer is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit
- Subjects' wound score on ISDA tool is Grade 1 or 2.
Key exclusion criteria (17 listed)
- Subject has a known life expectancy of < 1 year
- Subject or caregiver is unable to manage the Natrox® device (charge and change batteries daily)
- Subject has ulcers that are completely necrotic or if the clinician feels it is clinically necessary to cover the wound surface in gel or creams that would prevent the transmission of oxygen to the wound surface.
- Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
- Subject currently being treated for an active malignant disease or subjects with history of malignancy within the wound.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natrox® Oxygen Wound TherapyA battery-operated device which delivers pure humidified oxygen to the wound bed through water electrolysis via a sterile oxygen delivery system. | Device | Intervention arm |
Primary outcome
Number of Participants That Achieve Complete Wound Closure During the Twelve Week Study and the Percentage Change in Participant Ulcer Size at 12 Weeks From Baseline.
Time frame: Twelve (12) weeks from Time 0
Photographic wound evaluation and measurements were conducted utilizing an AI-driven computerized planimetry imaging system (Tissue Analytics, Inc., Baltimore, MD USA).15 This system obtained both 2D and 3D assessments of the wound at each visit through a standardized mobile device; in addition, the lead investigator reviewed all digital images.
Percentage Reduction in Ulcer Area (cm^2).
Time frame: Twelve (12) weeks from Time 0
Wound size change over time using a wound imaging measurement system. Percentage change in ulcer area was calculated on the basis of area change from the start of the study to the final recorded value. Any healed ulcer was recorded as having achieved 100% reduction in area; positive values indicate a reduction in size over the 12-week period while negative values indicate that the ulcer increased in size.
2 secondary outcomes
Level of Pain of the Wound
Time frame: Up to twelve (12) weeks from Time 0
Number of Adverse Events
Time frame: Up to twelve (12) weeks from time 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Serena study director
SerenaGroup, Inc.
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natrox® Oxygen Wound Therapy in people with Diabetic Foot Ulcer and Surgical Wound, run by Inotec AMD Limited at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Achieve Complete Wound Closure During the Twelve Week Study and the Percentage Change in Participant Ulcer Size at 12 Weeks From Baseline. (time frame: Twelve (12) weeks from Time 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.